EP2869867B1 - Humidity detection device for a device for monitoring access to a patient - Google Patents

Humidity detection device for a device for monitoring access to a patient Download PDF

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Publication number
EP2869867B1
EP2869867B1 EP13733956.0A EP13733956A EP2869867B1 EP 2869867 B1 EP2869867 B1 EP 2869867B1 EP 13733956 A EP13733956 A EP 13733956A EP 2869867 B1 EP2869867 B1 EP 2869867B1
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EP
European Patent Office
Prior art keywords
patient
detecting moisture
moisture
resilient
textile material
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Not-in-force
Application number
EP13733956.0A
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German (de)
French (fr)
Other versions
EP2869867A1 (en
Inventor
Alexander Schrörs
John Heppe
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Fresenius Medical Care Deutschland GmbH
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Fresenius Medical Care Deutschland GmbH
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Publication of EP2869867A1 publication Critical patent/EP2869867A1/en
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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3621—Extra-corporeal blood circuits
    • A61M1/367—Circuit parts not covered by the preceding subgroups of group A61M1/3621
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3621—Extra-corporeal blood circuits
    • A61M1/3653—Interfaces between patient blood circulation and extra-corporal blood circuit
    • A61M1/3656—Monitoring patency or flow at connection sites; Detecting disconnections
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/50—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests having means for preventing re-use, or for indicating if defective, used, tampered with or unsterile
    • A61M5/5086—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests having means for preventing re-use, or for indicating if defective, used, tampered with or unsterile for indicating if defective, used, tampered with or unsterile
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01M—TESTING STATIC OR DYNAMIC BALANCE OF MACHINES OR STRUCTURES; TESTING OF STRUCTURES OR APPARATUS, NOT OTHERWISE PROVIDED FOR
    • G01M3/00—Investigating fluid-tightness of structures
    • G01M3/02—Investigating fluid-tightness of structures by using fluid or vacuum
    • G01M3/04—Investigating fluid-tightness of structures by using fluid or vacuum by detecting the presence of fluid at the leakage point
    • G01M3/16—Investigating fluid-tightness of structures by using fluid or vacuum by detecting the presence of fluid at the leakage point using electric detection means
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01M—TESTING STATIC OR DYNAMIC BALANCE OF MACHINES OR STRUCTURES; TESTING OF STRUCTURES OR APPARATUS, NOT OTHERWISE PROVIDED FOR
    • G01M3/00—Investigating fluid-tightness of structures
    • G01M3/02—Investigating fluid-tightness of structures by using fluid or vacuum
    • G01M3/04—Investigating fluid-tightness of structures by using fluid or vacuum by detecting the presence of fluid at the leakage point
    • G01M3/16—Investigating fluid-tightness of structures by using fluid or vacuum by detecting the presence of fluid at the leakage point using electric detection means
    • G01M3/18—Investigating fluid-tightness of structures by using fluid or vacuum by detecting the presence of fluid at the leakage point using electric detection means for pipes, cables or tubes; for pipe joints or seals; for valves; for welds; for containers, e.g. radiators
    • G01M3/183—Investigating fluid-tightness of structures by using fluid or vacuum by detecting the presence of fluid at the leakage point using electric detection means for pipes, cables or tubes; for pipe joints or seals; for valves; for welds; for containers, e.g. radiators for pipe joints or seals
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01M—TESTING STATIC OR DYNAMIC BALANCE OF MACHINES OR STRUCTURES; TESTING OF STRUCTURES OR APPARATUS, NOT OTHERWISE PROVIDED FOR
    • G01M3/00—Investigating fluid-tightness of structures
    • G01M3/02—Investigating fluid-tightness of structures by using fluid or vacuum
    • G01M3/04—Investigating fluid-tightness of structures by using fluid or vacuum by detecting the presence of fluid at the leakage point
    • G01M3/16—Investigating fluid-tightness of structures by using fluid or vacuum by detecting the presence of fluid at the leakage point using electric detection means
    • G01M3/18—Investigating fluid-tightness of structures by using fluid or vacuum by detecting the presence of fluid at the leakage point using electric detection means for pipes, cables or tubes; for pipe joints or seals; for valves; for welds; for containers, e.g. radiators
    • G01M3/186—Investigating fluid-tightness of structures by using fluid or vacuum by detecting the presence of fluid at the leakage point using electric detection means for pipes, cables or tubes; for pipe joints or seals; for valves; for welds; for containers, e.g. radiators for containers, e.g. radiators
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3621—Extra-corporeal blood circuits
    • A61M1/3653—Interfaces between patient blood circulation and extra-corporal blood circuit
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/15—Detection of leaks

Definitions

  • the invention relates to a device for detecting moisture for a device for monitoring access to a patient for a device with which a liquid is supplied to a patient via a hose line and / or a liquid is discharged from the patient, in particular for monitoring the vascular access at an extracorporeal blood treatment, in particular for monitoring a central venous catheter in acute dialysis.
  • the invention relates to a device for monitoring access to a patient having a device for detecting moisture.
  • the invention relates to a method for producing a device for detecting moisture for connection to a device for monitoring a patient access.
  • the known extracorporeal blood treatment devices include, for example, dialysis devices and cell separators that require access to the patient's vasculature.
  • extracorporeal blood treatment the patient is bled via an arterial tubing with an arterial puncture cannula, which is delivered to the patient via a venous tubing is returned with a venous puncture cannula.
  • a central venous catheter is used on the patient's neck as patient access.
  • Luer-Lock connection For connecting catheters and tubing for the preparation of a patient access is generally used in the medical field known luer connection system whose connecting parts comprise an inner and an outer cone.
  • This connection system is called Luer-Lock connection, if the inner and outer cone to secure the connection is extended by a screw thread.
  • Luer-Lock connections offer a very high level of safety, it has been shown in practice that the connecting parts can become detached due to improper handling, material defects or frequent use, or micro-cracks can occur in the material.
  • the US 2010/0228231 therefore proposes to secure the connecting parts of a Luer-Lock connection system with an additional fixation of the connecting parts against unintentional loosening.
  • the known devices for monitoring a vascular access which have a device for detecting moisture in order to be able to detect the leakage of blood at the puncture site.
  • the known devices for detecting moisture which are used in the known patient access monitoring devices, are designed as a pad to be placed on the puncture site.
  • the pad consists of an absorbent material in which a moisture sensor is embedded.
  • Devices for detecting moisture from an absorbent material which is placed on the skin of the patient for example, from WO 2006/008866 A1 . US 2005/0038325 A1 and US Pat. No. 6,445,304 B1 known.
  • the known pads are characterized in that the moisture sensor is embedded in the absorbent material and the absorbent material is placed on the skin of the patient.
  • the WO 99/24145 describes a device for detecting moisture, which has a closable with a lid housing in which a moisture sensor is arranged. To carry out the cannulas and tubing openings are provided in the housing.
  • the disadvantage is that the housing with the moisture sensor is relatively expensive to produce in large quantities and is relatively difficult to handle in practice.
  • the US 2002/198483 A1 describes a device for detecting moisture, which has a moisture sensor to be attached to the skin of the patient and a sensor holder for attaching the sensor.
  • the sensor holder may be attached to the puncture site with one or more bands, which may be made of different materials, such as rigid or elastic materials.
  • a device that has a band-shaped moisture sensor that can be placed, for example, around the patient's arm.
  • the tape-shaped moisture sensor is attached to the patient's arm with a fastener element constructed in the manner of a belt buckle.
  • the invention has for its object to provide a cost-effective to produce in large quantities device for detecting moisture, which is easy to handle and offers a high level of comfort. Another object of the invention is to provide a device for monitoring access to a patient with such a device for detecting moisture. An object of the invention is also to provide a method for the cost-effective production of a device for detecting moisture in large quantities.
  • the device according to the invention for detecting moisture has a moisture sensor, which is designed as an electrically conductive structure.
  • the humidity sensor of the device according to the invention is connected to a device for monitoring access to a patient.
  • the inventive device for detecting moisture is characterized in that at least a portion or portion of the device as a resilient Fastening element with a hose line and / or a connection system of a hose line encompassing sections is formed.
  • the fastening element designed in the manner of a clip allows the device for detecting moisture to be fastened quickly and securely to a hose line or a hose line connection system. Additional fasteners are not required for this purpose. For example, it is not necessary to fix the device with an adhesive tape on the tubing, the connection system or the skin of the patient. This simplifies the handling of the device.
  • the device according to the invention can be fastened in particular in the region of the hose line to which there is a connection system, for example a Luer connection system.
  • a connection system for example a Luer connection system.
  • the device only needs to be placed around the connection system so that the connection point can be monitored for leaks.
  • the device according to the invention can easily be removed again from the tubing after the treatment, which is of particular importance when used for monitoring a central venous catheter.
  • the device can also be easily detached from the tubing during treatment.
  • the device according to the invention can easily be exchanged for a new device during the treatment.
  • the device according to the invention may have one or more resilient fastening elements. With several resilient fasteners, the security of the fixation of the device to the hose can be increased.
  • the device according to the invention may have different dimensions in order to be adapted to the different dimensions of the vascular access. It is crucial that the sections of the resilient fastening element securely surround the hose line or the connection system with the respective diameter.
  • the inventive device is designed as a one-piece, at least partially, resilient body.
  • the device is formed as an elongate body which can be snap-fitted to the tubing or tubing connection system.
  • the resilient fastening element is formed as an annular body which is slotted in the longitudinal direction. To insert the hose, the fastener needs only to be spread apart, with the fastener closes again under the spring tension. It is advantageous that when a tensile stress on the electrical connection line between the device for detecting moisture and the monitoring device, the device according to the invention can be solved, so that the patient access is not claimed to train.
  • the handling of the device according to the invention is further improved in that the annular body in the region of the slot has portions which are bent on both sides to the outside.
  • the bent portions form a guide for inserting the hose.
  • the device according to the invention preferably has an outer liquid-impermeable layer facing the patient and an inner fluid-absorbent layer facing away from the patient. This ensures that exiting blood at the hose connection point directly to the moisture sensor. Furthermore, it is avoided that sweat from the skin of the patient reaches the moisture sensor, so that false alarms are avoided.
  • a particularly preferred embodiment of the invention provides that the absorbent material is a textile material having the electrically conductive structure.
  • the electrically conductive structure may be embedded in the textile material or applied to the textile material.
  • the device can be produced from a composite of a preferred textile material with an electrically conductive structure and a thermally deformable carrier material in large numbers simply by the fact that the composite of the textile material and the carrier material is thermally deformed to form the resilient fasteners.
  • the inventive devices can be produced inexpensively in large quantities.
  • the electrically conductive structure of the moisture sensor preferably has at least one electrical conductor track embedded in the textile material.
  • the textile material is preferably a fabric with nonconductive warp threads and nonconductive weft threads as well as conductive warp threads and conductive weft threads, which are arranged in such a way that the at least one electrical conductor track is formed.
  • Such a fabric with an electrically conductive structure is in the WO 2011/116943 described in detail.
  • the device according to the invention preferably has connection contacts for electrical contacting of the moisture sensor. But it is also possible that an electrical connection line is led out of the device according to the invention, which is connected to the monitoring device.
  • connection contacts are formed on the end piece of an elongate section of the device.
  • connection contacts are sufficiently spatially separated from the humidity sensor. Therefore, unlike the area where the humidity sensor is located, the area of electrical contact need not be sterile. This is particularly advantageous in the monitoring of central venous catheters.
  • the device according to the invention has two mutually spaced sections, which are designed as resilient fastening elements.
  • This embodiment allows the fixation of the device according to the invention with the connecting parts of a hose, which are in particular Luer lock collectors.
  • the distance between the two resilient fastening elements is dimensioned such that the connecting parts of the hose line come to rest between the fastening elements.
  • Another preferred embodiment provides a third resilient fastener disposed between the first and second fasteners.
  • the third resilient fastener preferably has a greater length than the first and second fastener elements.
  • the device can be fixed to the connecting parts of the hose, in which the connecting parts are enclosed by the third fastening element snapping. As a result, the security of the fixation of the device according to the invention on the hose is further increased.
  • the inventive device of the composite of a textile material and a deformable plastic material can be sterilized without great technical effort and provided sterile as a disposable sensor in a suitable packaging.
  • the device according to the invention for monitoring access to a patient has the device according to the invention for detecting moisture, which is connected to the monitoring device.
  • the monitoring device may trigger an audible and / or visual and / or tactile alarm when moisture is detected.
  • a control signal can be generated for an intervention in the control of the device with which a liquid is supplied to the patient via a hose line and / or a liquid is discharged from the patient.
  • the inventive device for monitoring a patient access may form a separate unit or be part of the device, with the patient a Liquid supplied and / or liquid is discharged from the patient, in particular be part of the extracorporeal blood treatment device. If the monitoring device according to the invention is part of the blood treatment device, the monitoring device can make use of specific components or components that are present in the blood treatment device anyway.
  • Fig. 1 shows the essential components of a blood treatment device, in particular hemodialysis device A for acute dialysis, which has a device B for monitoring a vascular access, in particular a vascular access to a central venous catheter.
  • the monitoring device B is part of the hemodialysis device A.
  • the hemodialysis apparatus A has a dialyzer 1, which is subdivided by a semipermeable membrane 2 into a blood chamber 3 and a dialysis fluid chamber 4.
  • the vascular access to the patient is carried out with a central venous catheter 5, which is connected to the neck of the patient.
  • the central venous catheter 5 is part of the extracorporeal blood circulation I, which is only hinted at, which includes the blood chamber 3 of the dialyzer 1 and comprises tubing 6, 7.
  • a blood pump 8 is provided to convey the blood in the extracorporeal circuit.
  • the dialysis fluid circuit II of the dialysis machine A comprises a dialysis fluid source 10, to which a dialysis fluid supply line 11 is connected, which leads to the inlet of the dialysis fluid chamber 4 of the dialyzer 1. From the outlet of the dialysis fluid chamber 4 of the dialyzer 1, a dialysis fluid discharge line 12 departs, which leads to an outlet 13. In the dialysis fluid removal 12 a dialysis fluid pump 14 is connected.
  • the control of the dialysis device takes over a central control unit 15 which controls the blood and Dialysiersammlungspumpe 8, 14 via control lines 16, 17.
  • the central control unit 15 is connected via a data line 18 to an alarm unit 19, which gives an optical and / or acoustic and / or tactile alarm in the event of a malfunction.
  • the monitoring device B shown only schematically serves in the present embodiment for monitoring a Luer-lock connection 9 with the connecting parts 9A and 9B for connecting the central venous catheter 5 to a tubing 9C of the extracorporeal blood circulation I.
  • the monitoring device B has a device 50 for detecting moisture, which is arranged at the hose connection point 21.
  • This humidity sensor 50 is in Fig. 1 shown only schematically.
  • the monitoring device B has an evaluation device 22, which is electrically connected via a connecting line 23 with the humidity sensor 50.
  • the connection line 23 is connected to the humidity sensor 50 with an electrical connector 23A.
  • the evaluation device 22 is connected to the central control unit 15 of the dialysis machine A.
  • the evaluation device 22 of the monitoring device B In the event that blood exits the hose joint 21 and humidifies the humidity sensor 50, the evaluation device 22 of the monitoring device B generates a control signal which the central control unit 15 receives via the data line 24, which intervenes in the blood treatment.
  • the control unit 15 stops the blood pump 8 and generates an alarm signal, so that the alarm unit 19 gives an audible and / or visual and / or tactile alarm.
  • Fig. 2 shows an embodiment of the device for detecting moisture 50 in a perspective view.
  • the device 50 is made by thermally deforming a composite of an absorbent textile material and a thermoformable substrate.
  • the material composite and the manufacturing process are described with reference to the FIGS. 4 to 7 described in detail.
  • the humidity detecting device 50 is formed as an elongated body which can be snap-fixed to a tubing, not shown, or a tubing connection system.
  • the device is divided into a proximal section 51 for fixing a tubing, not shown, or a connection system of the tubing and a distal Section 52 to which a connector for electrical connection to the monitoring device is connected.
  • the middle portion 53 of the proximal portion 51 is formed as a resilient fastener 54 for the unillustrated tubing or tubing connection system.
  • the middle fastening element 54 is a sleeve-shaped body which is slotted in the longitudinal direction. In the region of the slot 55, the middle fastening element 54 has outwardly bent portions 56A, 56B.
  • Fig. 3 shows the proximal portion 51 of the device for detecting moisture in an enlarged view, in which the hose line, not shown, which consists of two hose line sections, which are connected by means of connecting parts.
  • the connection parts are the well-known Luer connection parts 9A and 9B ( Fig. 1 ).
  • the luer lock connection parts of the hose line are enclosed by the two resilient sections 54A, 54B of the middle fastening element 54, so that the hose line is fixed.
  • the inner diameter of the central fastening element 54 therefore corresponds approximately to the outer diameter of the Luer-lock connection parts.
  • the insertion of the connecting parts is facilitated by the outwardly bent portions 56A, 56B of the central fastening element 54, in that the two sections 54A, 54B of the central fastening element 54 can spread apart with the inclined surfaces supported on the connecting parts.
  • the length of the central fastening element 54 corresponds approximately to the length of both connecting parts.
  • the middle fastening element 54 is adjoined by a further, proximal, resilient fastening element 59 and a distal, resilient fastening element 61.
  • the proximal and distal fasteners 59, 61 are longitudinally slotted sleeve-shaped bodies having a smaller inner diameter than the middle resilient fastener 54.
  • the distal and proximal fasteners have the same inner diameter.
  • Both fasteners 59, 61 have the Hose line encompassing portions 59A, 59B and 61A, 61B, respectively. In the region of the slots 62 and 63, both fastening elements 59, 61 have sections 64A, 64B and 65A, 65B, which are bent outwards.
  • the proximal and distal fastener 59, 61 is separated from the central fastener 54 by V-shaped notches 77, 78. Since the inner diameter of the proximal and distal attachment members 59, 61 corresponds to the outer diameter of the tubing, the tubing is additionally fixed to the proximal and distal attachment members. Similarly, the proximal and distal fasteners constitute stops for the tubing connector parts because the inner diameter of the proximal and distal fasteners 59, 61 is smaller than the outer diameter of the tubing tubing connection parts.
  • the device If the device is to be subjected to tension in order to detect moisture, it can easily be displaced longitudinally with a clearance determined by the distance of the proximal and distal fastening element, so that the tensile force is scarcely transmitted to the central venous catheter. This fulfills the function of a "predetermined breaking point".
  • the distal portion 52 of the moisture detection device is not thermally deformed.
  • the distal portion 52 is a flat strip 79, at the end portion 52A of which the unillustrated fitting of the connecting lead leading to the monitoring device is connected.
  • On the top of the end piece 52A are the terminals 66 of the humidity sensor of the device for detecting moisture.
  • On the end piece 52A side lugs 67, 68 are formed, which form a stop for the connector, not shown.
  • the humidity sensor will be described below with reference to FIGS FIGS. 4 to 6 described.
  • the device according to the invention for detecting moisture is produced from a material composite of an absorbent textile material, in particular a multilayer fabric 69 and a thermally deformable carrier material 70.
  • Fig. 4 shows a section through the composite material.
  • the bond between the fabric 69 and the carrier material 70 can take place, for example, by means of an adhesive layer 70A. Lamination under high pressure can thereby be avoided. Too much pressure during laminating under pressure could have a negative effect on the printed conductor structure in the textile material or damage the printed conductors.
  • the multi-layer fabric consists of electrically conductive and electrically non-conductive warp and weft threads (monofilaments, carbon fibers, silver-plated polyamide yarn) in Fig. 4 only hinted at.
  • the electrically conductive and electrically non-conductive warp and weft threads 71 are arranged such that the fabric has a lower layer, a middle layer and an upper layer.
  • the electrically conductive structure of printed conductors forms the moisture sensor of the device for detecting moisture.
  • Such a consisting of warp and weft yarn moisture sensor is in the WO 2011/116943 described in detail, to which reference is expressly made.
  • FIGS. 5 and 6 show in plan view the composite material of the device for detecting moisture prior to thermal deformation.
  • the two embodiments of Fig. 5 and Fig. 6 differ only by the layout of the humidity sensor.
  • the reference numerals of FIGS. 1 and 2 used for the designation of the individual sections of the device for detecting moisture.
  • the electrically conductive structure 72 of the moisture sensor consists of longitudinal conductor tracks 73 and transverse tracks 74, which are electrically contacted at the intersections designated 75 and are electrically isolated from each other at the intersection points indicated at 76.
  • connection contacts 66 At the ends of the longitudinal conductor tracks 73 are the connection contacts 66 which are arranged offset to one another in this exemplary embodiment.
  • the humidity sensor has a higher sensitivity than the embodiment of Fig. 5 because the number of tracks is larger.
  • the humidity sensor is from Fig. 6 also sensitive in the edge regions of the central fastening element 54.
  • the sensitivity of the humidity sensor of Fig. 5 it is sufficient because the tissue is an absorbent material, such as blood, for example.
  • the V-shaped notches 77, 78 between the resilient fasteners facilitate insertion of the tubing. Since the device for detecting moisture is snapping fixed to the tubing, the device can be easily withdrawn from the tubing.
  • the respective diameter of the proximal attachment member 59 and the distal attachment member 61 and the middle attachment member 54 may be different. In particular, the diameters of the proximal and distal fasteners 59, 61 may be smaller than the diameter of the central fastener 54.
  • the V-shaped notches 77, 78 in FIGS FIGS. 5 and 6 have in the illustrated development radii, which can be adjusted according to the diameter of the proximal and distal fastener 59, 61, respectively.
  • the length of the strip-shaped section 52 is dimensioned such that the connection piece of the moisture sensor is sufficiently far away from the sterile area.
  • the thermoformable support material 70 is a material that retains a permanent set under the influence of temperature and is resilient after deformation.
  • the fabric 69 can be laminated, for example, with a rigid thermoplastic film as a carrier material.
  • the temperature required for the thermal deformation depends on the carrier material. The temperature should be in a range that does not affect the properties of the fabric, such as the hydrophilic properties, and does not damage the contact and insulation sites, etc.
  • thermoplastic film 70 fulfills the function of moisture barrier to moisture from the outside.
  • the carrier material 70 made of plastic for example, be a plastic film with a thickness of about 250 .mu.m, which can be made of two polyester films with a thickness of about 125 .mu.m by the films are laminated with their seal layer facing each other. In a further laminating process, the carrier material 70 is connected to the fabric 69. After cutting out the in the FIGS. 5 and 6 shown contour of the composite material is thermally deformed so that in the figures FIGS. 2 and 3 shown three-dimensional shape arises. The thermal deformation can be carried out, for example, under the action of hot air or infrared radiation, as a result of which the sealing layer melts between the polyester films.
  • the three-dimensional shape can for example be predetermined by a suitable core, which has a cylindrical shape in the present embodiment. After melting the sealing layer of the polyester films of composite material then takes in the FIGS. 2 and 3 shown shape. But it is also possible to deform a thermoplastic film.
  • Fig. 7 shows the individual process steps for the production of the device according to the invention for detecting moisture.
  • a first production step I the fabric 69 and the carrier material 70 are produced in webs as roll goods.
  • fabric 69 and backing material 70 are bonded together by an adhesive layer 70A.
  • a further production step III in the FIGS. 5 or 6 isolated sections cut out of the web.
  • the process step of thermal deformation (IV) of the isolated sections is processed by a tool in the three-dimensional shape fixed. The shape of the tools for die and core thereby determine the outer contour of the sensor. Die and core are heated during thermal deformation and then cooled.
  • process step V of the in-process control and release and process step VI of the assembly is followed by process step V of the in-process control and release and process step VI of the assembly.
  • the individual devices for detecting moisture can be protected against damage in a dimensionally stable packaging.
  • the devices can also be packaged in flexible packaging when inserts are used to protect against compression.

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  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • General Physics & Mathematics (AREA)
  • Physics & Mathematics (AREA)
  • Biomedical Technology (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Cardiology (AREA)
  • External Artificial Organs (AREA)

Description

Die Erfindung betrifft eine Vorrichtung zur Erkennung von Feuchtigkeit für eine Vorrichtung zur Überwachung eines Zugangs zu einem Patienten für eine Einrichtung, mit der über eine Schlauchleitung eine Flüssigkeit einem Patienten zugeführt und/oder eine Flüssigkeit von dem Patienten abgeführt wird, insbesondere zur Überwachung des Gefäßzugangs bei einer extrakorporalen Blutbehandlung, insbesondere zur Überwachung eines zentralvenösen Katheters bei der akuten Dialyse. Darüber hinaus betrifft die Erfindung eine Vorrichtung zur Überwachung eines Zugangs zu einem Patienten, die über eine Vorrichtung zur Erkennung von Feuchtigkeit verfügt. Des Weiteren betrifft die Erfindung ein Verfahren zur Herstellung einer Vorrichtung zur Erkennung von Feuchtigkeit zum Anschluss an eine Vorrichtung zur Überwachung eines Patientenzugangs.The invention relates to a device for detecting moisture for a device for monitoring access to a patient for a device with which a liquid is supplied to a patient via a hose line and / or a liquid is discharged from the patient, in particular for monitoring the vascular access at an extracorporeal blood treatment, in particular for monitoring a central venous catheter in acute dialysis. Moreover, the invention relates to a device for monitoring access to a patient having a device for detecting moisture. Furthermore, the invention relates to a method for producing a device for detecting moisture for connection to a device for monitoring a patient access.

Auf dem Gebiet der Medizintechnik sind verschiedene Einrichtungen bekannt, mit denen über eine Schlauchleitung Patienten Flüssigkeiten entnommen oder Flüssigkeiten den Patienten zugeführt werden können. Dabei erfolgt der Zugang zu den Patienten im Allgemeinen mit einem Katheter zum Einführen in Körperorgane oder einer Kanüle zum Punktieren von Gefäßen. Während der Untersuchung oder Behandlung ist ein ordnungsgemäßer Zugang zu dem Patienten sicher zu stellen. Daher ist es erforderlich, den Patientenzugang zu überwachen.Various devices are known in the field of medical technology with which liquids can be taken from a hose line or liquids can be supplied to the patient. The access to the patients generally takes place with a catheter for insertion into body organs or a cannula for puncturing vessels. During the examination or treatment, proper access to the patient must be ensured. Therefore, it is necessary to monitor patient access.

Einen ordnungsgemäßen Zugang zu dem Patienten setzen insbesondere auch die extrakorporalen Blutbehandlungsvorrichtungen voraus, die über einen extrakorporalen Blutkreislauf verfügen. Zu den bekannten extrakorporalen Blutbehandlungsvorrichtungen zählen beispielsweise Dialysevorrichtungen und Zellseparatoren, die einen Zugang zu dem Gefäßsystem des Patienten erforderlich machen. Bei der extrakorporalen Blutbehandlung wird dem Patienten über eine arterielle Schlauchleitung mit einer arteriellen Punktionskanüle Blut entnommen, das dem Patienten über eine venöse Schlauchleitung mit einer venösen Punktionskanüle wieder zugeführt wird. Bei der akuten Dialyse auf Intensivstationen wird als Patientenzugang ein zentralvenöser Katheter am Hals des Patienten eingesetzt.Proper access to the patient also requires in particular the extracorporeal blood treatment devices which have an extracorporeal blood circulation. The known extracorporeal blood treatment devices include, for example, dialysis devices and cell separators that require access to the patient's vasculature. In extracorporeal blood treatment, the patient is bled via an arterial tubing with an arterial puncture cannula, which is delivered to the patient via a venous tubing is returned with a venous puncture cannula. In acute dialysis in intensive care units, a central venous catheter is used on the patient's neck as patient access.

Trotz regelmäßiger Überwachung des Gefäßzugangs durch das Krankenhauspersonal besteht grundsätzlich die Gefahr, dass die Punktionskanüle unbemerkt aus dem Blutgefäß des Patienten herausrutscht oder sich eine Schlauchverbindung löst. Zur Überwachung des Gefäßzugangs sind verschiedene Vorrichtungen unterschiedlicher Ausbildung bekannt. Die bekannten Überwachungsvorrichtungen greifen im Allgemeinen auf die standardmäßig in den Blutbehandlungsvorrichtungen vorhandenen Sicherheitsvorrichtungen zurück, die bei einem nicht ordnungsgemäßen Gefäßzugang eine sofortige Unterbrechung des extrakorporalen Blutkreislaufs auslösen.Despite regular monitoring of the vascular access by the hospital staff there is always the danger that the puncture cannula slipped unnoticed out of the blood vessel of the patient or dissolves a hose connection. For monitoring the vascular access various devices of different training are known. The known monitoring devices generally rely on the standard safety devices present in the blood treatment devices which, in the event of improper vascular access, trigger an immediate interruption of the extracorporeal blood circulation.

Zum Anschluss von Kathetern und Schlauchleitungen für die Herstellung eines Patientenzugangs findet im Allgemeinen das im medizinischen Bereich bekannte Luer-Verbindungssystem Verwendung, dessen Verbindungsteile einen Innen- und einen Außenkonus umfassen. Dieses Verbindungssystem wird als Luer-Lock-Verbindung bezeichnet, wenn der Innen- und Außenkonus zur Sicherung der Verbindung um ein Schraubgewinde erweitert ist. Obwohl die Luer-Lock-Verbindungen eine sehr hohe Sicherheit bieten, hat sich in der Praxis gezeigt, dass sich die Verbindungsteile bei unsachgemäßer Handhabung, bei Materialfehlern oder zu häufigem Gebrauch lösen oder Mikrorisse im Material auftreten können. Die US 2010/0228231 schlägt daher vor, die Verbindungsteile eines Luer-Lock-Verbindungssystems mit einer zusätzlichen Fixierung der Verbindungsteile gegen unbeabsichtigtes Lösen zu sichern.For connecting catheters and tubing for the preparation of a patient access is generally used in the medical field known luer connection system whose connecting parts comprise an inner and an outer cone. This connection system is called Luer-Lock connection, if the inner and outer cone to secure the connection is extended by a screw thread. Although the Luer-Lock connections offer a very high level of safety, it has been shown in practice that the connecting parts can become detached due to improper handling, material defects or frequent use, or micro-cracks can occur in the material. The US 2010/0228231 therefore proposes to secure the connecting parts of a Luer-Lock connection system with an additional fixation of the connecting parts against unintentional loosening.

Es sind Vorrichtungen zur Überwachung eines Gefäßzugangs bekannt, die über eine Vorrichtung zur Erkennung von Feuchtigkeit verfügen, um an der Punktionsstelle das Austreten von Blut erkennen zu können. Die bekannten Vorrichtungen zur Erkennung von Feuchtigkeit, die bei den bekannten Überwachungsvorrichtungen für den Patientenzugang Verwendung finden, sind als auf die Punktionsstelle aufzulegendes Pad ausgebildet. Das Pad besteht aus einem saugfähigen Material, in das ein Feuchtigkeitssensor eingebettet ist.There are known devices for monitoring a vascular access, which have a device for detecting moisture in order to be able to detect the leakage of blood at the puncture site. The known devices for detecting moisture, which are used in the known patient access monitoring devices, are designed as a pad to be placed on the puncture site. The pad consists of an absorbent material in which a moisture sensor is embedded.

Vorrichtungen zum Detektieren von Feuchtigkeit aus einem saugfähigen Material, das auf die Haut des Patienten aufgelegt wird, sind beispielsweise aus der WO 2006/008866 A1 , US 2005/0038325 A1 und US 6,445,304 B1 bekannt. Die bekannten Pads zeichnen sich dadurch aus, dass der Feuchtigkeitssensor in das saugfähige Material eingebettet ist und das saugfähige Material auf die Haut des Patienten aufgelegt wird.Devices for detecting moisture from an absorbent material which is placed on the skin of the patient, for example, from WO 2006/008866 A1 . US 2005/0038325 A1 and US Pat. No. 6,445,304 B1 known. The known pads are characterized in that the moisture sensor is embedded in the absorbent material and the absorbent material is placed on the skin of the patient.

Die WO 99/24145 beschreibt eine Vorrichtung zur Erkennung von Feuchtigkeit, die ein mit einem Deckel verschließbares Gehäuse aufweist, in dem ein Feuchtigkeitssensor angeordnet ist. Zur Durchführung der Kanülen und Schlauchleitungen sind in dem Gehäuse Durchbrüche vorgesehen. Nachteilig ist, dass das Gehäuse mit dem Feuchtigkeitssensor in großen Stückzahlen relativ kostspielig herzustellen ist und in der Praxis nur relativ schwierig zu handhaben ist.The WO 99/24145 describes a device for detecting moisture, which has a closable with a lid housing in which a moisture sensor is arranged. To carry out the cannulas and tubing openings are provided in the housing. The disadvantage is that the housing with the moisture sensor is relatively expensive to produce in large quantities and is relatively difficult to handle in practice.

Die US 2002/198483 A1 beschreibt eine Vorrichtung zur Erkennung von Feuchtigkeit, die einen an der Haut des Patienten zu befestigenden Feuchtigkeitssensor und einen Sensorhalter zur Befestigung des Sensors aufweist. Der Sensorhalter kann an der Punktionsstelle mit einem oder mehreren Bändern befestigt werden, die aus unterschiedlichen Materialien, beispielsweise starren oder elastischen Materialien, bestehen können.The US 2002/198483 A1 describes a device for detecting moisture, which has a moisture sensor to be attached to the skin of the patient and a sensor holder for attaching the sensor. The sensor holder may be attached to the puncture site with one or more bands, which may be made of different materials, such as rigid or elastic materials.

Aus der WO 2009/075592 A2 ist eine Vorrichtung bekannt, die einen bandförmigen Feuchtigkeitssensor aufweist, der beispielsweise um den Arm des Patienten gelegt werden kann. Der bandförmige Feuchtigkeitssensor wird an dem Arm des Patienten mit einem in der Art einer Gürtelschnalle ausgebildeten Befestigungselement befestigt.From the WO 2009/075592 A2 For example, a device is known that has a band-shaped moisture sensor that can be placed, for example, around the patient's arm. The tape-shaped moisture sensor is attached to the patient's arm with a fastener element constructed in the manner of a belt buckle.

Der Erfindung liegt die Aufgabe zugrunde, eine in großen Stückzahlen kostengünstig herzustellende Vorrichtung zur Erkennung von Feuchtigkeit zu schaffen, die einfach zu handhaben ist und einen hohen Tragekomfort bietet. Eine weitere Aufgabe der Erfindung liegt darin, eine Vorrichtung zur Überwachung eines Zugangs zu einem Patienten mit einer derartigen Vorrichtung zur Erkennung von Feuchtigkeit zu schaffen. Eine Aufgabe der Erfindung ist auch ein Verfahren zur kostengünstigen Herstellung einer Vorrichtung zur Erkennung von Feuchtigkeit in großen Stückzahlen anzugeben.The invention has for its object to provide a cost-effective to produce in large quantities device for detecting moisture, which is easy to handle and offers a high level of comfort. Another object of the invention is to provide a device for monitoring access to a patient with such a device for detecting moisture. An object of the invention is also to provide a method for the cost-effective production of a device for detecting moisture in large quantities.

Die Lösung dieser Aufgaben erfolgt erfindungsgemäß mit den Merkmalen der unabhängigen Ansprüche. Die Gegenstände der abhängigen Ansprüche betreffen vorteilhafte Ausführungsformen der Erfindung.The solution of these objects is achieved according to the invention with the features of the independent claims. The subject matters of the dependent claims relate to advantageous embodiments of the invention.

Die erfindungsgemäße Vorrichtung zur Erkennung von Feuchtigkeit weist einen Feuchtigkeitssensor auf, der als eine elektrisch leitende Struktur ausgebildet ist. Der Feuchtigkeitssensor der erfindungsgemäßen Vorrichtung wird an eine Vorrichtung zur Überwachung eines Zugangs zu einem Patienten angeschlossen.The device according to the invention for detecting moisture has a moisture sensor, which is designed as an electrically conductive structure. The humidity sensor of the device according to the invention is connected to a device for monitoring access to a patient.

Die erfindungsgemäße Vorrichtung zur Erkennung von Feuchtigkeit zeichnet sich dadurch aus, dass zumindest ein Teilstück oder Abschnitt der Vorrichtung als ein federndes Befestigungselement mit eine Schlauchleitung und/oder ein Verbindungssystem einer Schlauchleitung umgreifenden Abschnitten ausgebildet ist. Das in der Art eines Clips ausgebildete Befestigungselement erlaubt es, die Vorrichtung zur Erkennung von Feuchtigkeit an einer Schlauchleitung oder einem Schlauchleitungsverbindungssystem schnell und sicher zu befestigen. Zusätzliche Befestigungsmittel sind hierzu nicht erforderlich. Beispielsweise ist es nicht erforderlich, die Vorrichtung mit einem Klebeband an der Schlauchleitung, dem Verbindungssystem oder der Haut des Patienten zu fixieren. Dadurch wird die Handhabung der Vorrichtung vereinfacht.The inventive device for detecting moisture is characterized in that at least a portion or portion of the device as a resilient Fastening element with a hose line and / or a connection system of a hose line encompassing sections is formed. The fastening element designed in the manner of a clip allows the device for detecting moisture to be fastened quickly and securely to a hose line or a hose line connection system. Additional fasteners are not required for this purpose. For example, it is not necessary to fix the device with an adhesive tape on the tubing, the connection system or the skin of the patient. This simplifies the handling of the device.

Die erfindungsgemäße Vorrichtung kann insbesondere in dem Bereich der Schlauchleitung befestigt werden, an dem sich ein Verbindungssystem, beispielsweise ein Luer-Verbindungssystem befindet. Hierzu braucht die Vorrichtung nur um das Verbindungssystem gelegt zu werden, so dass sich die Verbindungsstelle auf Leckagen überwachen lässt.The device according to the invention can be fastened in particular in the region of the hose line to which there is a connection system, for example a Luer connection system. For this purpose, the device only needs to be placed around the connection system so that the connection point can be monitored for leaks.

Während eine zusätzliche Sicherung einer Luer-Verbindung, die in der US 2010/0228231 beschrieben ist, nur das Lösen der Verbindung verhindern kann, erlaubt die erfindungsgemäße Vorrichtung auch die Erkennung eines langsamen Blutverlustes, beispielsweise in Folge von Handhabungs- oder Materialfehlern der Schlauchverbindung.While an additional backup of a luer connection, in the US 2010/0228231 is described, only the release of the compound can prevent the device of the invention also allows the detection of a slow blood loss, for example, as a result of handling or material defects of the hose connection.

Darüber hinaus ist es von Vorteil, dass sich die erfindungsgemäße Vorrichtung nach der Behandlung wieder leicht von der Schlauchleitung abnehmen lässt, was insbesondere bei der Verwendung zur Überwachung eines zentralvenösen Katheters von Bedeutung ist. Die Vorrichtung kann auch während der Behandlung leicht von der Schlauchleitung gelöst werden. Auch kann die erfindungsgemäße Vorrichtung während der Behandlung leicht gegen eine neue Vorrichtung ausgetauscht werden.Moreover, it is advantageous that the device according to the invention can easily be removed again from the tubing after the treatment, which is of particular importance when used for monitoring a central venous catheter. The device can also be easily detached from the tubing during treatment. Also, the device according to the invention can easily be exchanged for a new device during the treatment.

Die erfindungsgemäße Vorrichtung kann über einen oder mehrere federnde Befestigungselemente verfügen. Mit mehreren federnden Befestigungselementen kann die Sicherheit der Fixierung der Vorrichtung an der Schlauchleitung noch erhöht werden.The device according to the invention may have one or more resilient fastening elements. With several resilient fasteners, the security of the fixation of the device to the hose can be increased.

Die erfindungsgemäße Vorrichtung kann unterschiedliche Abmessungen haben, um an die unterschiedlichen Dimensionen der Gefäßzugänge angepasst zu sein. Entscheidend ist, dass die Abschnitte des federnden Befestigungselements die Schlauchleitung oder das Verbindungssystem mit dem jeweiligen Durchmesser sicher umgreifen.The device according to the invention may have different dimensions in order to be adapted to the different dimensions of the vascular access. It is crucial that the sections of the resilient fastening element securely surround the hose line or the connection system with the respective diameter.

Die erfindungsgemäße Vorrichtung ist als ein einstückiger, zumindest bereichsweise, federelastischer Körper ausgebildet. Vorzugsweise ist die Vorrichtung als ein langgestreckter Körper ausgebildet, der sich einschnappend an der Schlauchleitung oder des Schlauchleitungsverbindungssystems fixieren lässt. Eine weitere bevorzugte Ausführungsform sieht vor, dass das federnde Befestigungselement als ein ringförmiger Körper ausgebildet ist, der in Längsrichtung geschlitzt ist. Zum Einlegen der Schlauchleitung braucht das Befestigungselement nur aufgespreizt zu werden, wobei sich das Befestigungselement wieder unter der Federspannung schließt. Dabei ist vorteilhaft, dass bei einer Zugbeanspruchung der elektrischen Verbindungsleitung zwischen der Vorrichtung zur Erkennung von Feuchtigkeit und der Überwachungsvorrichtung sich die erfindungsgemäße Vorrichtung lösen kann, so dass der Patientenzugang nicht auf Zug beansprucht wird.The inventive device is designed as a one-piece, at least partially, resilient body. Preferably, the device is formed as an elongate body which can be snap-fitted to the tubing or tubing connection system. A further preferred embodiment provides that the resilient fastening element is formed as an annular body which is slotted in the longitudinal direction. To insert the hose, the fastener needs only to be spread apart, with the fastener closes again under the spring tension. It is advantageous that when a tensile stress on the electrical connection line between the device for detecting moisture and the monitoring device, the device according to the invention can be solved, so that the patient access is not claimed to train.

Die Handhabung der erfindungsgemäßen Vorrichtung wird noch dadurch verbessert, dass der ringförmige Körper im Bereich des Schlitzes Abschnitte aufweist, die zu beiden Seiten nach außen umgebogen sind. Die umgebogenen Abschnitte bilden eine Führung zum Einlegen der Schlauchleitung.The handling of the device according to the invention is further improved in that the annular body in the region of the slot has portions which are bent on both sides to the outside. The bent portions form a guide for inserting the hose.

Die erfindungsgemäße Vorrichtung weist vorzugsweise eine dem Patienten zugewandte außenliegende für Flüssigkeit nicht durchlässige Schicht und eine dem Patienten abgewandte innenliegende für Flüssigkeit saugfähige Schicht auf. Dadurch wird erreicht, dass an der Schlauchverbindungsstelle austretendes Blut unmittelbar an den Feuchtigkeitssensor gelangt. Weiterhin wird vermieden, dass Schweiß von der Haut des Patienten zu dem Feuchtigkeitssensor gelangt, so dass Fehlalarme vermieden werden.The device according to the invention preferably has an outer liquid-impermeable layer facing the patient and an inner fluid-absorbent layer facing away from the patient. This ensures that exiting blood at the hose connection point directly to the moisture sensor. Furthermore, it is avoided that sweat from the skin of the patient reaches the moisture sensor, so that false alarms are avoided.

Eine besonders bevorzugte Ausführungsform der Erfindung sieht vor, dass das saugfähige Material ein textiles Material ist, das die elektrisch leitende Struktur aufweist. Die elektrisch leitende Struktur kann in das textile Material eingebettet oder auf das textile Material aufgebracht sein.A particularly preferred embodiment of the invention provides that the absorbent material is a textile material having the electrically conductive structure. The electrically conductive structure may be embedded in the textile material or applied to the textile material.

Die besonderen Vorteile der erfindungsgemäßen Vorrichtung liegen insbesondere darin, dass sich die Vorrichtung aus einem Verbund von einem vorzugsweisen textilen Material mit einer elektrisch leitfähigen Struktur und einem thermisch verformbaren Trägermaterial in großen Stückzahlen einfach dadurch herstellen lässt, dass der Verbund aus dem textilen Material und dem Trägermaterial unter Ausbildung der federnden Befestigungselemente thermisch verformt wird. Mit diesem Herstellungsverfahren lassen sich die erfindungsgemäßen Vorrichtungen in großen Stückzahlen kostengünstig herstellen.The particular advantages of the device according to the invention are in particular that the device can be produced from a composite of a preferred textile material with an electrically conductive structure and a thermally deformable carrier material in large numbers simply by the fact that the composite of the textile material and the carrier material is thermally deformed to form the resilient fasteners. With this manufacturing method, the inventive devices can be produced inexpensively in large quantities.

Die elektrisch leitende Struktur des Feuchtigkeitssensors weist vorzugsweise mindestens eine elektrische Leiterbahn auf, die in das textile Material eingebettet ist. Vorzugsweise ist das textile Material ein Gewebe mit nicht-leitfähigen Kettfäden und nicht-leitfähigen Schussfäden sowie leitfähigen Kettfäden und leitfähigen Schussfäden, die derart angeordnet sind, dass die mindestens eine elektrische Leiterbahn ausgebildet ist. Ein derartiges Gewebe mit einer elektrisch leitfähigen Struktur ist in der WO 2011/116943 im Einzelnen beschrieben.The electrically conductive structure of the moisture sensor preferably has at least one electrical conductor track embedded in the textile material. The textile material is preferably a fabric with nonconductive warp threads and nonconductive weft threads as well as conductive warp threads and conductive weft threads, which are arranged in such a way that the at least one electrical conductor track is formed. Such a fabric with an electrically conductive structure is in the WO 2011/116943 described in detail.

Die erfindungsgemäße Vorrichtung verfügt vorzugsweise über Anschlusskontakte zur elektrischen Kontaktierung des Feuchtigkeitssensors. Es ist aber auch möglich, dass eine elektrische Verbindungsleitung aus der erfindungsgemäßen Vorrichtung herausgeführt wird, die an die Überwachungsvorrichtung angeschlossen wird.The device according to the invention preferably has connection contacts for electrical contacting of the moisture sensor. But it is also possible that an electrical connection line is led out of the device according to the invention, which is connected to the monitoring device.

Eine weitere bevorzugte Ausführungsform sieht vor, dass die Anschlusskontakte am Endstück eines langgestreckten Teilstücks der Vorrichtung ausgebildet sind. Dadurch sind die Anschlusskontakte von dem Feuchtigkeitssensor ausreichend räumlich getrennt. Daher braucht der Bereich der elektrischen Kontaktierung im Gegensatz zu dem Bereich, an dem sich der Feuchtigkeitssensor befindet, nicht steril zu sein. Dies ist insbesondere bei der Überwachung von zentralvenösen Kathetern von Vorteil.A further preferred embodiment provides that the connection contacts are formed on the end piece of an elongate section of the device. As a result, the connection contacts are sufficiently spatially separated from the humidity sensor. Therefore, unlike the area where the humidity sensor is located, the area of electrical contact need not be sterile. This is particularly advantageous in the monitoring of central venous catheters.

Bei einer besonders bevorzugten Ausführungsform weist die erfindungsgemäße Vorrichtung zwei im Abstand zueinander angeordnete Teilstücke auf, die als federnde Befestigungselemente ausgebildet sind. Diese Ausführungsform erlaubt die Fixierung der erfindungsgemäßen Vorrichtung mit den Verbindungsteilen einer Schlauchleitung, die insbesondere Luer-Lock-Kollektoren sind. Der Abstand der beiden federnden Befestigungselemente ist derart bemessen, dass die Verbindungsteile der Schlauchleitung zwischen den Befestigungselementen zu liegen kommen.In a particularly preferred embodiment, the device according to the invention has two mutually spaced sections, which are designed as resilient fastening elements. This embodiment allows the fixation of the device according to the invention with the connecting parts of a hose, which are in particular Luer lock collectors. The distance between the two resilient fastening elements is dimensioned such that the connecting parts of the hose line come to rest between the fastening elements.

Eine weitere bevorzugte Ausführungsform sieht ein drittes federndes Befestigungselement vor, das zwischen dem ersten und zweiten Befestigungselement angeordnet ist. Das dritte federnde Befestigungselement hat vorzugsweise eine größere Länge als das erste und zweite Befestigungselement. An dem dritten federnden Befestigungselement kann die Vorrichtung an den Verbindungsteilen der Schlauchleitung fixiert werden, in dem die Verbindungsteile von dem dritten Befestigungselement einschnappend umschlossen werden. Dadurch wird die Sicherheit der Fixierung der erfindungsgemäßen Vorrichtung an der Schlauchleitung noch weiter erhöht.Another preferred embodiment provides a third resilient fastener disposed between the first and second fasteners. The third resilient fastener preferably has a greater length than the first and second fastener elements. At the third resilient fastening element, the device can be fixed to the connecting parts of the hose, in which the connecting parts are enclosed by the third fastening element snapping. As a result, the security of the fixation of the device according to the invention on the hose is further increased.

Die erfindungsgemäße Vorrichtung aus dem Verbund von einem Textilmaterial und einem verformbaren Kunststoffmaterial kann ohne großen technischen Aufwand sterilisiert werden und als Einwegsensor in einer geeigneten Verpackung steril bereitgestellt werden.The inventive device of the composite of a textile material and a deformable plastic material can be sterilized without great technical effort and provided sterile as a disposable sensor in a suitable packaging.

Die erfindungsgemäße Vorrichtung zur Überwachung eines Zugangs zu einem Patienten, insbesondere zur Überwachung eines zentralvenösen Katheters verfügt über die erfindungsgemäße Vorrichtung zur Erkennung von Feuchtigkeit, die an die Überwachungsvorrichtung angeschlossen wird. Die Überwachungsvorrichtung kann einen akustischen und/oder optischen und/oder taktilen Alarm auslösen, wenn Feuchtigkeit detektiert wird. Auch kann ein Steuersignal für einen Eingriff in die Steuerung der Einrichtung erzeugt werden, mit der über eine Schlauchleitung eine Flüssigkeit dem Patienten zugeführt und/oder eine Flüssigkeit von dem Patienten abgeführt wird.The device according to the invention for monitoring access to a patient, in particular for monitoring a central venous catheter, has the device according to the invention for detecting moisture, which is connected to the monitoring device. The monitoring device may trigger an audible and / or visual and / or tactile alarm when moisture is detected. Also, a control signal can be generated for an intervention in the control of the device with which a liquid is supplied to the patient via a hose line and / or a liquid is discharged from the patient.

Die erfindungsgemäße Vorrichtung zur Überwachung eines Patientenzugangs kann eine separate Einheit bilden oder Bestandteil der Einrichtung sein, mit der dem Patienten eine Flüssigkeit zugeführt und/oder von dem Patienten Flüssigkeit abgeführt wird, insbesondere Bestandteil der extrakorporalen Blutbehandlungsvorrichtung sein. Wenn die erfindungsgemäße Überwachungsvorrichtung Bestandteil der Blutbehandlungsvorrichtung ist, kann die Überwachungsvorrichtung von bestimmten Baugruppen oder Bauteilen Gebrauch machen, die in der Blutbehandlungsvorrichtung ohnehin vorhanden sind.The inventive device for monitoring a patient access may form a separate unit or be part of the device, with the patient a Liquid supplied and / or liquid is discharged from the patient, in particular be part of the extracorporeal blood treatment device. If the monitoring device according to the invention is part of the blood treatment device, the monitoring device can make use of specific components or components that are present in the blood treatment device anyway.

Im Folgenden wird ein Ausführungsbeispiel der erfindungsgemäßen Vorrichtung unter Bezugnahme auf die Zeichnungen näher erläutert.In the following, an embodiment of the device according to the invention will be explained in more detail with reference to the drawings.

Es zeigen:

Fig. 1
die wesentlichen Komponenten einer Blutbehandlungsvorrichtung, die über eine Vorrichtung zur Überwachung eines Gefäßzugangs verfügt,
Fig. 2
die erfindungsgemäße Vorrichtung zur Erkennung von Feuchtigkeit in perspektivischer Darstellung,
Fig. 3
den Ausschnitt A von Fig. 2 in vergrößerter Darstellung,
Fig. 4
einen Schnitt durch den Verbund von textilem Material und thermisch verformbaren Trägermaterial,
Fig. 5
ein erstes Ausführungsbeispiel der erfindungsgemäßen Vorrichtung vor der Verformung des Verbundes von textilem Material und thermisch verformbarem Trägermaterial,
Fig. 6
ein zweites Ausführungsbeispiel der erfindungsgemäßen Vorrichtung vor der Verformung des Materialverbundes und
Fig. 7
eine schematische Darstellung zur Veranschaulichung der Prozessschritte zur Herstellung der erfindungsgemäßen Vorrichtung.
Show it:
Fig. 1
the essential components of a blood treatment device having a device for monitoring vascular access,
Fig. 2
the device according to the invention for detecting moisture in a perspective view,
Fig. 3
the section A of Fig. 2 in an enlarged view,
Fig. 4
a section through the composite of textile material and thermally deformable carrier material,
Fig. 5
a first embodiment of the device according to the invention before the deformation of the composite of textile material and thermally deformable carrier material,
Fig. 6
A second embodiment of the device according to the invention prior to deformation of the composite material and
Fig. 7
a schematic representation for illustrating the process steps for the production of the device according to the invention.

Fig. 1 zeigt die wesentlichen Komponenten einer Blutbehandlungsvorrichtung, insbesondere Hämodialysevorrichtung A für die Akutdialyse, die über eine Vorrichtung B zur Überwachung eines Gefäßzugangs, insbesondere eines Gefäßzugangs mit einem zentralvenösen Katheter verfügt. Bei dem vorliegenden Ausführungsbeispiel ist die Überwachungsvorrichtung B Bestandteil der Hämodialysevorrichtung A. Zunächst wird die Dialysevorrichtung unter Bezugnahme auf Fig. 1 beschrieben. Fig. 1 shows the essential components of a blood treatment device, in particular hemodialysis device A for acute dialysis, which has a device B for monitoring a vascular access, in particular a vascular access to a central venous catheter. In the present embodiment, the monitoring device B is part of the hemodialysis device A. First, the dialysis device will be described with reference to FIG Fig. 1 described.

Die Hämodialysevorrichtung A weist einen Dialysator 1 auf, der durch eine semipermeable Membran 2 in eine Blutkammer 3 und eine Dialysierflüssigkeitskammer 4 unterteilt ist. Der Gefäßzugang zum Patienten erfolgt mit einem zentralvenösen Katheter 5, der am Hals des Patienten angeschlossen wird. Der zentralvenöse Katheter 5 ist Teil des nur andeutungsweise dargestellten extrakorporalen Blutkreislaufs I, der die Blutkammer 3 des Dialysators 1 einschließt und Schlauchleitungen 6, 7 umfasst. Zum Fördern des Bluts im extrakorporalen Kreislauf ist ein Blutpumpe 8 vorgesehen.The hemodialysis apparatus A has a dialyzer 1, which is subdivided by a semipermeable membrane 2 into a blood chamber 3 and a dialysis fluid chamber 4. The vascular access to the patient is carried out with a central venous catheter 5, which is connected to the neck of the patient. The central venous catheter 5 is part of the extracorporeal blood circulation I, which is only hinted at, which includes the blood chamber 3 of the dialyzer 1 and comprises tubing 6, 7. To convey the blood in the extracorporeal circuit, a blood pump 8 is provided.

Der Dialysierflüssigkeitskreislauf II der Dialysevorrichtung A umfasst eine Dialyseflüssigkeitsquelle 10, an der eine Dialysierflüssigkeitszuführleitung 11 angeschlossen ist, die zu dem Einlass der Dialysierflüssigkeitskammer 4 des Dialysators 1 führt. Von dem Auslass der Dialysierflüssigkeitskammer 4 des Dialysators 1 geht eine Dialysierflüssigkeitsabführleitung 12 ab, die zu einem Auslass 13 führt. In die Dialysierflüssigkeitsabführleitung 12 ist eine Dialysierflüssigkeitspumpe 14 geschaltet.The dialysis fluid circuit II of the dialysis machine A comprises a dialysis fluid source 10, to which a dialysis fluid supply line 11 is connected, which leads to the inlet of the dialysis fluid chamber 4 of the dialyzer 1. From the outlet of the dialysis fluid chamber 4 of the dialyzer 1, a dialysis fluid discharge line 12 departs, which leads to an outlet 13. In the dialysis fluid removal 12 a dialysis fluid pump 14 is connected.

Die Steuerung der Dialysevorrichtung übernimmt eine zentrale Steuereinheit 15, die über Steuerleitungen 16, 17 die Blut- und Dialysierflüssigkeitspumpe 8, 14 ansteuert. Die zentrale Steuereinheit 15 ist über eine Datenleitung 18 mit einer Alarmeinheit 19 verbunden, die bei einem Störfall einen optischen und/oder akustischen und/oder taktilen Alarm gibt.The control of the dialysis device takes over a central control unit 15 which controls the blood and Dialysierflüssigkeitspumpe 8, 14 via control lines 16, 17. The central control unit 15 is connected via a data line 18 to an alarm unit 19, which gives an optical and / or acoustic and / or tactile alarm in the event of a malfunction.

Die nur schematisch dargestellte Überwachungsvorrichtung B dient bei dem vorliegenden Ausführungsbeispiel zur Überwachung einer Luer-Lock-Verbindung 9 mit den Verbindungsteilen 9A und 9B zum Anschluss des zentralvenösen Katheters 5 an eine Schlauchleitung 9C des extrakorporalen Blutkreislaufs I. Die Überwachungsvorrichtung B verfügt über eine Vorrichtung 50 zur Erkennung von Feuchtigkeit, die an der Schlauchverbindungsstelle 21 angeordnet wird. Dieser Feuchtigkeitssensor 50 ist in Fig. 1 nur schematisch dargestellt. Darüber hinaus verfügt die Überwachungsvorrichtung B über eine Auswerteinrichtung 22, die über eine Verbindungsleitung 23 mit dem Feuchtigkeitssensor 50 elektrisch verbunden ist. Die Verbindungsleitung 23 ist mit einem elektrischen Verbindungsstück 23A an den Feuchtigkeitssensor 50 angeschlossen.The monitoring device B shown only schematically serves in the present embodiment for monitoring a Luer-lock connection 9 with the connecting parts 9A and 9B for connecting the central venous catheter 5 to a tubing 9C of the extracorporeal blood circulation I. The monitoring device B has a device 50 for detecting moisture, which is arranged at the hose connection point 21. This humidity sensor 50 is in Fig. 1 shown only schematically. In addition, the monitoring device B has an evaluation device 22, which is electrically connected via a connecting line 23 with the humidity sensor 50. The connection line 23 is connected to the humidity sensor 50 with an electrical connector 23A.

Über eine Datenleitung 24 ist die Auswerteinrichtung 22 mit der zentralen Steuereinheit 15 der Dialysevorrichtung A verbunden. Für den Fall, dass Blut aus der Schlauchverbindungsstelle 21 austritt und den Feuchtigkeitssensor 50 befeuchtet, erzeugt die Auswerteinrichtung 22 der Überwachungsvorrichtung B ein Steuersignal, das die zentrale Steuereinheit 15 über die Datenleitung 24 empfängt, die einen Eingriff in die Blutbehandlung vornimmt. Die Steuereinheit 15 stoppt die Blutpumpe 8 und erzeugt ein Alarmsignal, sodass die Alarmeinheit 19 einen akustischen und/oder optischen und/oder taktilen Alarm gibt.Via a data line 24, the evaluation device 22 is connected to the central control unit 15 of the dialysis machine A. In the event that blood exits the hose joint 21 and humidifies the humidity sensor 50, the evaluation device 22 of the monitoring device B generates a control signal which the central control unit 15 receives via the data line 24, which intervenes in the blood treatment. The control unit 15 stops the blood pump 8 and generates an alarm signal, so that the alarm unit 19 gives an audible and / or visual and / or tactile alarm.

Nachfolgend wird ein Ausführungsbeispiel der erfindungsgemäßen Vorrichtung zur Erkennung von Feuchtigkeit unter Bezugnahme auf die Figuren 2 bis 6 im Einzelnen beschrieben.Hereinafter, an embodiment of the device according to the invention for detecting moisture with reference to the FIGS. 2 to 6 described in detail.

Fig. 2 zeigt ein Ausführungsbeispiel der Vorrichtung zur Erkennung von Feuchtigkeit 50 in perspektivischer Darstellung. Die Vorrichtung 50 ist durch thermisches Verformen eines Verbundes von einem saugfähigen textilen Material und einem thermisch verformbaren Trägermaterial hergestellt. Der Materialverbund und das Herstellungsverfahren werden unter Bezugnahme auf die Figuren 4 bis 7 im Einzelnen beschrieben. Fig. 2 shows an embodiment of the device for detecting moisture 50 in a perspective view. The device 50 is made by thermally deforming a composite of an absorbent textile material and a thermoformable substrate. The material composite and the manufacturing process are described with reference to the FIGS. 4 to 7 described in detail.

Die Vorrichtung 50 zur Erkennung von Feuchtigkeit ist als ein langgestreckter Körper ausgebildet, der sich an einer nicht dargestellten Schlauchleitung oder einem Schlauchleitungsverbindungssystem einschnappend fixieren lässt. Die Vorrichtung gliedert sich in einen proximalen Abschnitt 51 zur Fixierung einer nicht dargestellten Schlauchleitung oder einem Verbindungssystem der Schlauchleitung und einen distalen Abschnitt 52, an den ein Anschlussstück für den elektrischen Anschluss an die Überwachungsvorrichtung angeschlossen wird.The humidity detecting device 50 is formed as an elongated body which can be snap-fixed to a tubing, not shown, or a tubing connection system. The device is divided into a proximal section 51 for fixing a tubing, not shown, or a connection system of the tubing and a distal Section 52 to which a connector for electrical connection to the monitoring device is connected.

Der mittlere Abschnitt 53 des proximalen Abschnitts 51 ist als ein federndes Befestigungselement 54 für die nicht dargestellte Schlauchleitung oder das Schlauchleitungsverbindungssystem ausgebildet. Das mittlere Befestigungselement 54 ist ein hülsenförmiger Körper, der in Längsrichtung geschlitzt ist. Im Bereich des Schlitzes 55 weist das mittlere Befestigungselement 54 nach außen umgebogene Abschnitte 56A, 56B auf.The middle portion 53 of the proximal portion 51 is formed as a resilient fastener 54 for the unillustrated tubing or tubing connection system. The middle fastening element 54 is a sleeve-shaped body which is slotted in the longitudinal direction. In the region of the slot 55, the middle fastening element 54 has outwardly bent portions 56A, 56B.

Fig. 3 zeigt den proximalen Abschnitt 51 der Vorrichtung zur Erkennung von Feuchtigkeit in vergrößerter Darstellung, in den die nicht dargestellte Schlauchleitung, die aus zwei Schlauchleitungsabschnitten besteht, die mittels Verbindungsteilen miteinander verbunden sind. Bei den Verbindungsteilen handelt es sich um die allgemein bekannten Luer-Verbindungsteile 9A und 9B (Fig. 1). Fig. 3 shows the proximal portion 51 of the device for detecting moisture in an enlarged view, in which the hose line, not shown, which consists of two hose line sections, which are connected by means of connecting parts. The connection parts are the well-known Luer connection parts 9A and 9B ( Fig. 1 ).

Die Luer-Lock-Verbindungsteile der Schlauchleitung werden von den beiden federnden Abschnitten 54A, 54B des mittleren Befestigungselements 54 umschlossen, so dass die Schlauchleitung fixiert ist. Der Innendurchmesser des mittleren Befestigungselements 54 entspricht daher etwa dem Außendurchmesser der Luer-Lock-Verbindungsteile. Das Einführen der Verbindungsteile wird durch die nach außen umgebogenen Abschnitte 56A, 56B des mittleren Befestigungselements 54 erleichtert, indem die beiden Abschnitte 54A, 54B des mittleren Befestigungselements 54 mit den sich an den Verbindungsteilen abstützenden Schrägflächen aufspreizen können. Die Länge des mittleren Befestigungselements 54 entspricht etwa der Länge beiden Verbindungsteile.The luer lock connection parts of the hose line are enclosed by the two resilient sections 54A, 54B of the middle fastening element 54, so that the hose line is fixed. The inner diameter of the central fastening element 54 therefore corresponds approximately to the outer diameter of the Luer-lock connection parts. The insertion of the connecting parts is facilitated by the outwardly bent portions 56A, 56B of the central fastening element 54, in that the two sections 54A, 54B of the central fastening element 54 can spread apart with the inclined surfaces supported on the connecting parts. The length of the central fastening element 54 corresponds approximately to the length of both connecting parts.

An das mittlere Befestigungselement 54 schließt sich ein weiteres proximales federndes Befestigungselement 59 und ein distales federndes Befestigungselement 61 an. Das proximale und distale Befestigungselement 59, 61 sind in Längsrichtung geschlitzte hülsenförmige Körper, die einen kleineren Innendurchmesser als das mittlere federnde Befestigungselement 54 haben. Das distale und proximale Befestigungselement haben den gleichen Innendurchmesser. Beide Befestigungselemente 59, 61 weisen die Schlauchleitung umgreifende Abschnitte 59A, 59B bzw. 61A, 61B auf. Im Bereich der Schlitze 62 bzw. 63 weisen beide Befestigungselemente 59, 61 Abschnitte 64A, 64B bzw. 65A, 65B auf, die nach außen umgebogen sind.The middle fastening element 54 is adjoined by a further, proximal, resilient fastening element 59 and a distal, resilient fastening element 61. The proximal and distal fasteners 59, 61 are longitudinally slotted sleeve-shaped bodies having a smaller inner diameter than the middle resilient fastener 54. The distal and proximal fasteners have the same inner diameter. Both fasteners 59, 61 have the Hose line encompassing portions 59A, 59B and 61A, 61B, respectively. In the region of the slots 62 and 63, both fastening elements 59, 61 have sections 64A, 64B and 65A, 65B, which are bent outwards.

Das proximale und distale Befestigungselement 59, 61 ist von dem mittleren Befestigungselement 54 durch V-förmige Einschnitte 77, 78 getrennt. Da der Innendurchmesser des proximalen und distalen Befestigungselements 59, 61 dem Außendurchmesser der Schlauchleitung entspricht, ist die Schlauchleitung zusätzlich mit dem proximalen und distalen Befestigungselement fixiert. Gleichsam stellen das proximale und distale Befestigungselement Anschläge für die Verbindungsteile der Schlauchleitung dar, weil der Innendurchmesser des proximalen und distalen Befestigungselements 59, 61 kleiner als der Außendurchmesser der Verbindungsteile der Schlauleitung ist.The proximal and distal fastener 59, 61 is separated from the central fastener 54 by V-shaped notches 77, 78. Since the inner diameter of the proximal and distal attachment members 59, 61 corresponds to the outer diameter of the tubing, the tubing is additionally fixed to the proximal and distal attachment members. Similarly, the proximal and distal fasteners constitute stops for the tubing connector parts because the inner diameter of the proximal and distal fasteners 59, 61 is smaller than the outer diameter of the tubing tubing connection parts.

Wenn die Vorrichtung zur Erkennung von Feuchtigkeit auf Zug beansprucht werden sollte, kann sie mit einem durch den Abstand des proximalen und distalen Befestigungselements vorgegebenen Spiel leicht in Längsrichtung verschoben werden, so dass die Zugkraft kaum auf den zentralvenösen Katheter übertragen wird. Dies erfüllt die Funktion einer "Sollbruchstelle".If the device is to be subjected to tension in order to detect moisture, it can easily be displaced longitudinally with a clearance determined by the distance of the proximal and distal fastening element, so that the tensile force is scarcely transmitted to the central venous catheter. This fulfills the function of a "predetermined breaking point".

Der distale Abschnitt 52 der Vorrichtung zur Erkennung von Feuchtigkeit ist nicht thermisch verformt. Der distale Abschnitt 52 ist ein flacher Streifen 79, an dessen Endstück 52A das nicht dargestellte Anschlussstück der zu der Überwachungsvorrichtung führenden Verbindungsleitung angeschlossen wird. Auf der Oberseite des Endstücks 52A befinden sich die Anschlusskontakte 66 des Feuchtigkeitssensors der Vorrichtung zur Erkennung von Feuchtigkeit. An dem Endstück 52A sind seitliche Ansätze 67, 68 ausgebildet, die einen Anschlag für das nicht dargestellte Anschlussstück bilden. Der Feuchtigkeitssensor wird nachfolgend unter Bezugnahme auf die Figuren 4 bis 6 beschrieben.The distal portion 52 of the moisture detection device is not thermally deformed. The distal portion 52 is a flat strip 79, at the end portion 52A of which the unillustrated fitting of the connecting lead leading to the monitoring device is connected. On the top of the end piece 52A are the terminals 66 of the humidity sensor of the device for detecting moisture. On the end piece 52A side lugs 67, 68 are formed, which form a stop for the connector, not shown. The humidity sensor will be described below with reference to FIGS FIGS. 4 to 6 described.

Die erfindungsgemäße Vorrichtung zur Erkennung von Feuchtigkeit wird aus einem Materialverbund von einem saugfähigen textilen Material, insbesondere einem mehrlagigen Gewebe 69 und einem thermisch verformbaren Trägermaterial 70 hergestellt. Fig. 4 zeigt einen Schnitt durch den Materialverbund. Der Verbund zwischen Gewebe 69 und Trägermaterial 70 kann beispielsweise mittels einer Klebeschicht 70A erfolgen. Ein Laminieren unter hohem Druck kann dadurch umgangen werden. Eine zu starke Pressung beim Laminieren unter Druck könnte sich nämlich nachteilig auf die Leiterbahnstruktur in dem textilen Material auswirken bzw. die Leiterbahnen beschädigen.The device according to the invention for detecting moisture is produced from a material composite of an absorbent textile material, in particular a multilayer fabric 69 and a thermally deformable carrier material 70. Fig. 4 shows a section through the composite material. The bond between the fabric 69 and the carrier material 70 can take place, for example, by means of an adhesive layer 70A. Lamination under high pressure can thereby be avoided. Too much pressure during laminating under pressure could have a negative effect on the printed conductor structure in the textile material or damage the printed conductors.

Das Mehrlagengewebe besteht aus elektrisch leitfähigen und elektrisch nicht leitfähigen Kett- und Schussfäden (Monofilamente, Karbonfasern, versilbertes Polyamidgarn) die in Fig. 4 nur andeutungsweise dargestellt sind. Die elektrisch leitfähigen und elektrisch nicht-leitfähigen Kett- und Schussfäden 71 sind derart angeordnet, dass das Gewebe eine untere Lage, eine mittlere Lage und eine obere Lage aufweist.The multi-layer fabric consists of electrically conductive and electrically non-conductive warp and weft threads (monofilaments, carbon fibers, silver-plated polyamide yarn) in Fig. 4 only hinted at. The electrically conductive and electrically non-conductive warp and weft threads 71 are arranged such that the fabric has a lower layer, a middle layer and an upper layer.

Die elektrisch leitende Struktur von Leiterbahnen bildet den Feuchtigkeitssensor der Vorrichtung zur Erkennung von Feuchtigkeit. Ein derartiger aus Kett- und Schussfäden bestehender Feuchtigkeitssensor ist in der WO 2011/116943 im Einzelnen beschrieben, auf die ausdrücklich Bezug genommen wird.The electrically conductive structure of printed conductors forms the moisture sensor of the device for detecting moisture. Such a consisting of warp and weft yarn moisture sensor is in the WO 2011/116943 described in detail, to which reference is expressly made.

Die Figuren 5 und 6 zeigen in der Draufsicht den Materialverbund der Vorrichtung zur Erkennung von Feuchtigkeit vor der thermischen Verformung. Die beiden Ausführungsbeispiele von Fig. 5 und Fig. 6 unterscheiden sich nur durch das Layout des Feuchtigkeitssensors. Für die Bezeichnung der einzelnen Abschnitte der Vorrichtung zur Erkennung von Feuchtigkeit werden daher die Bezugszeichen der Figuren 1 und 2 verwendet.The FIGS. 5 and 6 show in plan view the composite material of the device for detecting moisture prior to thermal deformation. The two embodiments of Fig. 5 and Fig. 6 differ only by the layout of the humidity sensor. For the designation of the individual sections of the device for detecting moisture, therefore, the reference numerals of FIGS. 1 and 2 used.

Die elektrisch leitende Struktur 72 des Feuchtigkeitssensors besteht aus längslaufenden Leiterbahnen 73 und querverlaufenden Leiterbahnen 74, die an den mit 75 bezeichneten Kreuzungspunkten elektrisch kontaktiert und an den mit 76 bezeichneten Kreuzungspunkten elektrisch voneinander isoliert sind. An den Enden der längslaufenden Leiterbahnen 73 befinden sich die bei diesem Ausführungsbeispiel versetzt zueinander angeordneten Anschlusskontakte 66.The electrically conductive structure 72 of the moisture sensor consists of longitudinal conductor tracks 73 and transverse tracks 74, which are electrically contacted at the intersections designated 75 and are electrically isolated from each other at the intersection points indicated at 76. At the ends of the longitudinal conductor tracks 73 are the connection contacts 66 which are arranged offset to one another in this exemplary embodiment.

Die in Fig. 6 gezeigte Ausführungsform des Feuchtigkeitssensors hat eine höhere Sensitivität als die Ausführungsform von Fig. 5, da die Anzahl der Leiterbahnen größer ist. Darüber hinaus ist der Feuchtigkeitssensor von Fig. 6 auch in den Randbereichen des mittleren Befestigungselements 54 sensitiv. Die Sensitivität des Feuchtigkeitssensors von Fig. 5 ist allerdings ausreichend, da das Gewebe ein für Flüssigkeit, beispielsweise Blut, saugfähiges Material ist.In the Fig. 6 shown embodiment of the humidity sensor has a higher sensitivity than the embodiment of Fig. 5 because the number of tracks is larger. In addition, the humidity sensor is from Fig. 6 also sensitive in the edge regions of the central fastening element 54. The sensitivity of the humidity sensor of Fig. 5 However, it is sufficient because the tissue is an absorbent material, such as blood, for example.

Die V-förmigen Einschnitte 77, 78 zwischen den federnden Befestigungselementen erleichtern das Einführen der Schlauchleitung. Da die Vorrichtung zur Erkennung von Feuchtigkeit einschnappend an der Schlauchleitung festgelegt ist, kann die Vorrichtung leicht wieder von der Schlauchleitung abgezogen werden. Der jeweilige Durchmesser des proximalen Befestigungselements 59 und des distalen Befestigungselements 61 und des mittleren Befestigungselements 54 können unterschiedlich sein. Insbesondere können die Durchmesser des proximalen und des distalen Befestigungselements 59, 61 kleiner sein als der Durchmesser des mittleren Befestigungselements 54. Die V-förmigen Einschnitte 77, 78 in den Figuren 5 und 6 weisen in der dargestellten Abwicklung Radien auf, die jeweils entsprechend dem Durchmesser des proximalen und distalen Befestigungselements 59, 61 angepasst werden können. Die Länge des streifenförmigen Abschnitts 52 ist derart bemessen, dass das Anschlussstück des Feuchtigkeitssensors ausreichend weit von dem sterilen Bereich entfernt ist.The V-shaped notches 77, 78 between the resilient fasteners facilitate insertion of the tubing. Since the device for detecting moisture is snapping fixed to the tubing, the device can be easily withdrawn from the tubing. The respective diameter of the proximal attachment member 59 and the distal attachment member 61 and the middle attachment member 54 may be different. In particular, the diameters of the proximal and distal fasteners 59, 61 may be smaller than the diameter of the central fastener 54. The V-shaped notches 77, 78 in FIGS FIGS. 5 and 6 have in the illustrated development radii, which can be adjusted according to the diameter of the proximal and distal fastener 59, 61, respectively. The length of the strip-shaped section 52 is dimensioned such that the connection piece of the moisture sensor is sufficiently far away from the sterile area.

Das thermisch verformbare Trägermaterial 70 ist ein Material, das unter Temperatureinwirkung eine bleibende Verformung behält und nach der Verformung federelastisch ist. Das Gewebe 69 kann beispielsweise mit einer steifen thermoplastischen Folie als Trägermaterial kaschiert werden. Die für die thermische Verformung erforderliche Temperatur ist abhängig von dem Trägermaterial. Die Temperatur sollte in einem Bereich liegen, der die Eigenschaften des Gewebes, beispielsweise die hydrophilen Eigenschaften, nicht beeinträchtigt und nicht zu einer Beschädigung der Kontakt- und Isolationsstellen etc. führt.The thermoformable support material 70 is a material that retains a permanent set under the influence of temperature and is resilient after deformation. The fabric 69 can be laminated, for example, with a rigid thermoplastic film as a carrier material. The temperature required for the thermal deformation depends on the carrier material. The temperature should be in a range that does not affect the properties of the fabric, such as the hydrophilic properties, and does not damage the contact and insulation sites, etc.

Es ist grundsätzlich auch möglich, mit einer entsprechenden Wärmebehandlung nur das textile Material plastisch zu verformen, um eine dreidimensionale Struktur zu erhalten.In principle, it is also possible to plastically deform only the textile material with a corresponding heat treatment in order to obtain a three-dimensional structure.

Durch Einweben stärkerer Fäden in das Gewebe kann die mechanische Stabilität dabei verbessert werden. Allerdings hat der Materialverbund aus einer thermoplastischen Folie 70 und einem Gewebe 69 im Hinblick auf die mechanischen Eigenschaften wie Elastizität und Steifigkeit, die für die Handhabung und Beständigkeit des Sensors von Bedeutung sind, entscheidende Vorteile. Außerdem erfüllt die thermoplastische Folie die Funktion der Feuchtigkeitsbarriere gegen Feuchtigkeit von außen.By weaving stronger threads into the fabric, the mechanical stability can be improved. However, the composite material of a thermoplastic film 70 and a fabric 69 in view of the mechanical properties such as elasticity and stiffness, which are important for the handling and durability of the sensor, crucial advantages. In addition, the thermoplastic film fulfills the function of moisture barrier to moisture from the outside.

Das Trägermaterial 70 aus Kunststoff kann beispielsweise eine Kunststofffolie mit einer Dicke von ca. 250µm sein, die aus zwei Polyesterfolien mit einer Dicke von ca. 125µm hergestellt werden kann, indem die Folien mit ihrer Siegelschicht einander zugewandt miteinander laminiert werden. In einem weiteren Kaschierprozess wird das Trägermaterial 70 mit dem Gewebe 69 verbunden. Nach Ausschneiden der in den Figuren 5 und 6 gezeigten Kontur wird der Materialverbund derart thermisch verformt, so dass die in den Figuren Fig. 2 und 3 gezeigte dreidimensionale Form entsteht. Die thermische Verformung kann beispielsweise unter der Einwirkung von Heißluft oder Infrarotstrahlung erfolgen, wodurch die Siegelschicht zwischen den Polyesterfolien aufschmilzt. Die dreidimensionale Form kann beispielsweise durch einen geeigneten Kern vorgegeben werden, der bei dem vorliegenden Ausführungsbeispiel eine zylindrische Form hat. Nach dem Aufschmelzen der Siegelschicht der Polyesterfolien nimmt der Materialverbund dann die in den Figuren 2 und 3 gezeigte Form an. Es ist aber auch möglich, eine thermoplastische Folie zu verformen.The carrier material 70 made of plastic, for example, be a plastic film with a thickness of about 250 .mu.m, which can be made of two polyester films with a thickness of about 125 .mu.m by the films are laminated with their seal layer facing each other. In a further laminating process, the carrier material 70 is connected to the fabric 69. After cutting out the in the FIGS. 5 and 6 shown contour of the composite material is thermally deformed so that in the figures FIGS. 2 and 3 shown three-dimensional shape arises. The thermal deformation can be carried out, for example, under the action of hot air or infrared radiation, as a result of which the sealing layer melts between the polyester films. The three-dimensional shape can for example be predetermined by a suitable core, which has a cylindrical shape in the present embodiment. After melting the sealing layer of the polyester films of composite material then takes in the FIGS. 2 and 3 shown shape. But it is also possible to deform a thermoplastic film.

Fig. 7 zeigt die einzelnen Prozessschritte zur Herstellung der erfindungsgemäßen Vorrichtung zur Erkennung von Feuchtigkeit. Fig. 7 shows the individual process steps for the production of the device according to the invention for detecting moisture.

In einem ersten Produktionsschritt I werden das Gewebe 69 und das Trägermaterial 70 in Bahnen als Rollenware hergestellt. In einem nachfolgenden Kaschierprozess II werden Gewebe 69 und Trägermaterial 70 durch eine Klebeschicht 70A miteinander verbunden. Daraufhin werden in einem weiteren Produktionsschritt III die in den Figuren 5 oder 6 gezeigten Ausschnitte aus der Materialbahn vereinzelt. Daraufhin folgt der Prozessschritt der thermischen Verformung (IV) der vereinzelten Ausschnitte. Während der Verformung wird die ausgeschnittene Abwicklung durch ein Werkzeug in der dreidimensionalen Form fixiert. Die Form der Werkzeuge für Matrize und Kern bestimmen dabei die Außenkontur des Sensors. Matrize und Kern werden während des thermischen Verformens beheizt und danach gekühlt. Daran schließt sich der Prozessschritt V der Inprozesskontrolle und Freigabe sowie der Prozessschritt VI der Konfektionierung an.In a first production step I, the fabric 69 and the carrier material 70 are produced in webs as roll goods. In a subsequent laminating process II, fabric 69 and backing material 70 are bonded together by an adhesive layer 70A. Then in a further production step III in the FIGS. 5 or 6 isolated sections cut out of the web. This is followed by the process step of thermal deformation (IV) of the isolated sections. During deformation, the cut-out is processed by a tool in the three-dimensional shape fixed. The shape of the tools for die and core thereby determine the outer contour of the sensor. Die and core are heated during thermal deformation and then cooled. This is followed by process step V of the in-process control and release and process step VI of the assembly.

Die einzelnen Vorrichtungen zur Erkennung von Feuchtigkeit können in einer formfesten Verpackung vor Beschädigungen geschützt werden. Die Vorrichtungen können aber auch in flexiblen Verpackungen konfektioniert werden, wenn Einlegeteile zum Schutz vor dem Zusammendrücken verwendet werden.The individual devices for detecting moisture can be protected against damage in a dimensionally stable packaging. However, the devices can also be packaged in flexible packaging when inserts are used to protect against compression.

Claims (16)

  1. Device for detecting moisture for an arrangement for monitoring an access to a patient for a system by which, via a flexible line, a liquid is fed to a patient and/or a liquid is fed out from the patient, the device for detecting moisture having a moisture sensor which takes the form of an electrically conductive structure (72),
    characterised in that the device for detecting moisture takes the form of a one-piece body which is resilient at least in a region or regions, and that at least a part or portion of the device for detecting moisture takes the form of a resilient attaching element (54) having parts (54A, 54B) which fit round a flexible line and/or a system for connecting the flexible line.
  2. Device according to claim 1, characterised in that the device for detecting moisture takes the form of an elongated body.
  3. Device according to claim 1 or 2, characterised in that the at least one resilient attaching element (54) takes the form of an annular body which is slit in the longitudinal direction.
  4. Device according to claim 3, characterised in that the annular body has, in the region of the slit (55), sections (56A, 56B) which folded over in the outward direction on both sides.
  5. Device according to one of claims 1 to 4, characterised in that the device for detecting moisture has a layer not permeable to liquid which is adjacent to the patient and situated on the outside and a layer (69) absorbent of liquid which is remote from the patient and is situated on the inside.
  6. Device according to claims 5, characterised in that the layer (69) absorbent of liquid which is situated on the inside is a textile material which has the electrically conductive structure (72).
  7. Device according to claim 5 or 6, characterised in that the layer (70) situated on the outside is a layer of resilient plastics material which has been thermally deformed.
  8. Device according to claim 6 or 7, characterised in that the electrically conductive structure (72) has at least one electrical conductor (73, 74) which is embedded in the textile material (69).
  9. Device according to claim 8, characterised in that the textile material is a woven material (69) having non-conductive warp filaments and non-conductive weft filaments (71) and conductive warp filaments and conductive weft filaments (71), which are so arranged that the at least one conductor (73, 74) is formed.
  10. Device according to one of claims 1 to 9, characterised in that the device for detecting moisture has connecting contacts (66) to allow electrical contact to be made with the moisture sensor.
  11. Device according to claim 10, characterised in that the connecting contacts (66) are formed on the end-piece (52A) of an elongated sub-section (79) of the device for detecting moisture.
  12. Device according to one of claims 1 to 11, characterised in that the device for detecting moisture has two sub-sections or portions which are spaced apart from one another and which take the form of a first and a second resilient attaching element (59, 61).
  13. Device according to claim 12, characterised in that the device for detecting moisture has a third resilient attaching element (54) which is arranged between the first and second resilient attaching elements (59,61).
  14. Device according to claim 13, characterised in that the third resilient attaching element (54) is of a greater length in the longitudinal direction than the first and second attaching elements (59, 61).
  15. Device for monitoring an access to a patient for a system by which, via a flexible line, a liquid is fed to a patient and/or a liquid is fed out from the patient, characterised in that the monitoring arrangement (B) has a device (50) for detecting moisture according to one of claims 1 to 14.
  16. Method of producing a device for detecting moisture according to one of claims 1 to 14, having the following steps:
    application of a textile material (69) having an electrical conductive structure to a thermally deformable substrate material (70),
    cutting out from the textile material and the substrate material of a composite item having a preset outline,
    thermal deformation of the composite item comprising the textile material and the substrate material which has been cut out, and
    cooling of the thermally deformed composite item comprising the textile material and the substrate material.
EP13733956.0A 2012-07-09 2013-07-03 Humidity detection device for a device for monitoring access to a patient Not-in-force EP2869867B1 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201261669175P 2012-07-09 2012-07-09
DE102012013473.8A DE102012013473B4 (en) 2012-07-09 2012-07-09 Device for detecting moisture for a device for monitoring access to a patient
PCT/EP2013/001947 WO2014008991A1 (en) 2012-07-09 2013-07-03 Humidity detection device for a device for monitoring access to a patient

Publications (2)

Publication Number Publication Date
EP2869867A1 EP2869867A1 (en) 2015-05-13
EP2869867B1 true EP2869867B1 (en) 2017-08-30

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EP13733956.0A Not-in-force EP2869867B1 (en) 2012-07-09 2013-07-03 Humidity detection device for a device for monitoring access to a patient

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US (1) US9295791B2 (en)
EP (1) EP2869867B1 (en)
CN (1) CN104470556B (en)
DE (1) DE102012013473B4 (en)
WO (1) WO2014008991A1 (en)

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Publication number Publication date
US9295791B2 (en) 2016-03-29
DE102012013473B4 (en) 2018-02-22
US20140012199A1 (en) 2014-01-09
CN104470556B (en) 2016-11-23
DE102012013473A1 (en) 2014-01-09
CN104470556A (en) 2015-03-25
WO2014008991A1 (en) 2014-01-16
EP2869867A1 (en) 2015-05-13

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